Lifestyle Intervention for Obesity

(LIVE WELL Trial)

Overseen By Madison Kindred, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Disqualifiers: Cardiopulmonary disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

125 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the effectiveness of a physician led, multi-disciplinary approach to treating obesity that incorporates nutrition (mainly, using genetics to identify appropriate food intake), exercise, and motivational counseling. The investigators plan to recruit overweight/obese (BMI\>25) males and females to participate. Participants will be randomized to receive a personalized diet plan, or a standard care diet plan; both groups will participate in the exercise intervention. For a 6-month duration, both groups will be asked to improve their diet according to their dietary plan and participate in moderate-to-vigorous physical activity (gradual increase up to 300 min/week). The investigators intend to evaluate standard outcomes of weight loss, and assess for any predictors of positive outcomes. Following the six-month intervention, participants will complete a 3-month no contact phase. This no contact phase will provide insight into the effects of the study on weight loss maintenance. Our team also plans to address acceptability by providing evaluations to study participants and conducting interviews with a small subset of participants to improve the intervention for the future.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been stable on your medications for the past 3 months.

What data supports the effectiveness of the treatment Lifestyle Intervention for Healthy Change for obesity?

Research shows that lifestyle modification, which includes diet, exercise, and psychological support, can lead to an average weight loss of 8-10% over about 30 weeks. This approach has shown promise, especially when personalized and delivered through various methods like phone, internet, or community settings. ^{1 2 3 4 5}

Is the lifestyle intervention for obesity generally safe for humans?

Lifestyle interventions for obesity, which involve changing behaviors to reduce food intake and increase physical activity, are generally considered safe for humans. They have been shown to produce weight loss and health benefits, although maintaining weight loss can be challenging. ^{1 6 7 8 9}

How is the Lifestyle Intervention for Healthy Change treatment different from other obesity treatments?

The Lifestyle Intervention for Healthy Change treatment is unique because it combines support for changing diet and physical activity with weight management education, focusing on long-term adherence and personalization to individual needs, unlike some other treatments that may not emphasize these aspects. ^{2 5 8 10 11}

Research Team

Madison Kindred, PhD

Principal Investigator

Augusta University

Eligibility Criteria

This trial is for overweight or obese adults aged 18-40 with a BMI over 25, who are stable on medications, not pregnant, can walk unassisted, and own a smartphone. It excludes those with cardiopulmonary disease or recent weight fluctuations.

Inclusion Criteria

stable on medications for 3 months

weight stable (+/-5 pounds) for the past 3 months

I do not have heart or lung disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a personalized or standard care diet plan and participate in an exercise intervention for 6 months

6 months

Regular visits for dietary and exercise monitoring

No Contact Phase

Participants complete a 3-month no contact phase to assess weight loss maintenance

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lifestyle Intervention for Healthy Change

Trial Overview The study tests a physician-led approach to obesity treatment combining personalized dietary plans based on genetics (Nutrigenomix), exercise routines, and motivational counseling. Participants will follow their diet and exercise plan for six months.

Participant Groups

Group I: Nutrigenomix Experimental Treatment 3 Interventions

Participants in this group will be asked to complete an oral swab at baseline. This swab will indicate their dietary needs based on their genetic composition. These personalized dietary needs will be shared with the participant; the participant will be encouraged to follow their dietary plan for the duration of the study. Participants in this group will also gradually increase their physical activity up to 300 min/week at 6 months.

Group II: Control Active Control 3 Interventions

Participants in this group will receive a standard care dietary plan. They will also be asked to gradually increase their activity up to 300 min/week by 6 months.

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Findings from Research

Individuals with severe obesity experience a complex and dynamic process of maintaining lifestyle changes three years after intervention, characterized by ups and downs in their daily lives.

Support from healthcare providers and a collaborative, humanized approach are crucial for helping these individuals navigate the challenges of sustaining healthy living and making ongoing adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ups and downs of lifestyle modification: An existential journey among persons with severe obesity. Toft, BS., Hörberg, U., Rasmussen, B.[2022]

Lifestyle modifications for treating obesity are challenging to implement and sustain long-term, highlighting the need for effective strategies.

Simple and cost-effective interventions have shown potential benefits in specific populations, suggesting that targeted approaches may improve obesity treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. Tamir, O., Furmn-Assaf, S., Shemer, J.[2011]

Comprehensive lifestyle modification programs delivered in person can lead to an average weight loss of about 10% over 16-26 weeks, while web-based interventions typically result in around 5% weight loss, highlighting the effectiveness of in-person support.

Combining lifestyle changes with long-term medication use may enhance initial weight loss and help maintain weight loss over time, suggesting a multi-faceted approach could be beneficial for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy for obesity: where are we now? Sarwer, DB., von Sydow Green, A., Vetter, ML., et al.[2022]

Lifestyle modification therapy can lead to a significant weight loss of 8-10% over approximately 30 weeks for overweight and obese patients, combining diet, exercise, and behavioral strategies.

To enhance the effectiveness and sustainability of this therapy, new strategies such as individualized treatment, remote delivery via phone or internet, and integration with community programs or bariatric surgery have shown promising results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. Dalle Grave, R., Calugi, S., El Ghoch, M.[2022]

A lifestyle intervention program combining diet, exercise, and psychological support significantly improved lifestyle-related behaviors in 60 overweight and obese patients over 6 months, as evidenced by better scores in dietary caloric intake, physical activity, and healthy eating.

The program also led to positive changes in body composition parameters, indicating that such comprehensive interventions can effectively support weight management in a primary healthcare setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. Arrebola Vivas, E., Gómez-Candela, C., Fernández Fernández, C., et al.[2015]

Lifestyle interventions can lead to weight loss and health benefits, as shown in large randomized clinical trials, but not all participants achieve even a 5% reduction in body weight, and weight regain is a common issue.

Real-world studies show only modest weight loss from lifestyle changes, and there is currently no reimbursement model to support these interventions in medical office settings, highlighting the need for healthcare providers to understand both the potential and limitations of these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle-Based Obesity Care. Ryan, DH.[2023]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

A randomized clinical trial involving 445 participants showed that individual telephone counseling for obesity management significantly reduced weight regain compared to an email education control, with a posterior probability greater than 99%.

Participants receiving individual telephone counseling were more likely to achieve at least a 10% weight reduction (31.5%) compared to those in the control group (19.1%), indicating that personalized support can enhance long-term weight loss maintenance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. Perri, MG., Shankar, MN., Daniels, MJ., et al.[2020]

In the Look AHEAD trial, severely obese participants (BMI ≥40 kg/m²) who underwent an intensive lifestyle intervention (ILI) lost an average of 9.04% of their initial body weight after one year, which was significantly more than the 7.43% weight loss in overweight participants, showing that ILI is effective for severe obesity.

All groups, including severely obese participants, showed similar improvements in cardiovascular disease risk factors such as fitness, LDL cholesterol, and blood pressure, indicating that intensive lifestyle changes can benefit individuals regardless of their initial weight category.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial. Unick, JL., Beavers, D., Jakicic, JM., et al.[2022]

Lifestyle interventions that combine dietary changes, physical activity support, and weight management education are the first-line treatment for obesity, emphasizing their importance in addressing the global obesity epidemic.

The chapter highlights the need for personalized weight management programs to enhance effectiveness and long-term adherence, given the significant health risks associated with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. Roberts, SB., Anton, S., Dao, MC.[2022]

A new mathematical model was developed to predict weight changes based on dietary energy intake, using data from 8 longitudinal studies with 157 participants, which showed strong accuracy in its predictions (R² values of 0.83 and 0.91).

This model can help obese patients and their doctors set realistic long-term weight maintenance goals by calculating the necessary dietary changes, making it a practical tool for weight management professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. Hall, KD., Jordan, PN.[2023]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

The ups and downs of lifestyle modification: An existential journey among persons with severe obesity. [2022]

2. Israel pubmed.ncbi.nlm.nih.gov

[Lifestyle modification--a behavioral and educational challenge]. [2011]

3. England pubmed.ncbi.nlm.nih.gov

Behavior therapy for obesity: where are we now? [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle modification in the management of obesity: achievements and challenges. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness of a program for treatment of overweight and nonmorbid obesity in primary healthcare and its influence lifestyle modification]. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Lifestyle-Based Obesity Care. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Telehealth Extended Care for Maintenance of Weight Loss in Rural US Communities: A Randomized Clinical Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of lifestyle interventions for individuals with severe obesity and type 2 diabetes: results from the Look AHEAD trial. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Weight Loss Strategies. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Modeling weight-loss maintenance to help prevent body weight regain. [2023]